Proclinical is currently recruiting for an Associate Director of Biostatistics with a global biotechnology company located in Boston, MA. As the Associate Director, you will work with cross functional teams as the project biostatistician for one or more programs.
- Represent statistics in cross-functional project and study teams in multiple projects.
- Provide statistical input into Clinical Development Plans, Clinical Study Protocols, Clinical Study Reports, regulatory submission documents, and publications ensuring accurate deliverables.
- Perform sample size calculations, develop statistical analysis plans and lead TLF development.
- Perform statistical analyses and validate analysis results.
- Oversee outsourced statistical CRO activities and deliverables ensuring highest quality.
- Develop, implement and improve statistical processes and standards.
- Support and participate in the development of departmental strategies.
- Interact with global regulatory authorities.
Skills and Requirements:
- PhD or Masters in statistics or biostatistics.
- Six years (8 years for masters) of experience in the pharmaceutical industry and/or CRO including submission experience.
- Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R.
- Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking.
If you are having difficulty in applying or if you have any questions, please contact Felix Hook at (+1) 646-367-2617 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.